Prognostic Value of Transcranial Doppler Ultrasound in the Clinical Evolution of Patients With Acute Ischemic Stroke. The TRADE-AIS Study

ConditionStroke
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorJose Ivan Rodriguez de Molina Serrano

About this trial

This prospective observational study aims to determine whether specific parameters measured by transcranial Doppler ultrasound (TCD) can predict clinical outcomes in patients with acute ischemic stroke (AIS). The primary objective is to evaluate the association between middle cerebral artery (MCA) flow velocities and short-term neurological improvement. Secondary outcomes include the presence of collateral flow and flow patterns in relation to functional recovery measured by NIHSS and modified Rankin Scale (mRS) scores.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥ 18 years

Clinical diagnosis of acute ischemic stroke

Onset of symptoms ≤ 24 hours before admission

Underwent or will undergo transcranial Doppler ultrasound within 24 hours of symptom onset

Disqualifiers

Evidence of intracerebral hemorrhage on imaging

Inadequate temporal acoustic window for transcranial Doppler

Intubated or hemodynamically unstable prior to Doppler evaluation

Known diagnosis of neurodegenerative disease significantly affecting baseline neurological function (e.g., advanced dementia, Parkinson's disease)

Trial design

Design model

Single group

Treatments tested in this trial

  • Transcranial Doppler Ultrasound

    Diagnostic test

    A non-invasive bedside diagnostic procedure used to measure cerebral blood flow velocities and pulsatility index in intracranial arteries, primarily the middle cerebral artery (MCA). The test is performed within the first 24 hours of symptom onset using standard ultrasound equipment with a 2-MHz probe. The data collected is used solely for prognostic evaluation and does not influence treatment decisions.

Treatment groups

50 Participants
are divided into 1 treatment group
Group A: Inpatient Stroke confirmedOther 1 intervention

Trial outcomes

Primary outcomes

1

Change in NIHSS score from baseline to 72 hours

Neurological status will be assessed using the National Institutes of Health Stroke Scale (NIHSS) at baseline (upon admission) and again at 72 hours. The primary objective is to evaluate the correlation between initial transcranial Doppler (TCD) measurements-specifically, mean flow velocity and pulsatility index in the middle cerebral artery-and the degree of clinical improvement or deterioration, as reflected by changes in NIHSS score. A greater reduction in NIHSS score indicates better neurological recovery. The NIH Stroke Scale (NIHSS) is a standardized, 15-item clinical assessment tool used to evaluate the severity of neurologic deficits in patients with acute stroke. The total NIHSS score ranges from 0 to 42, where: 0 = no stroke symptoms Higher scores indicate greater stroke severity and worse neurological outcomes The scale includes assessments of level of consciousness, gaze, visual fields, motor strength, limb ataxia, sensory function, language, and neglect.

Time frame
72 hours

Secondary outcomes

1

Presence of collateral circulation associated with ≥ 4-point NIHSS improvement

Collateral circulation will be assessed using transcranial Doppler ultrasound within 24 hours of symptom onset. Collaterals will be defined as the presence of cross-flow or increased velocity in the anterior or posterior communicating arteries. Clinical improvement is defined as a reduction of ≥4 points on the NIHSS score from baseline to day 7. The association between collateral flow and neurological improvement will be analyzed. The NIH Stroke Scale (NIHSS) is a standardized, 15-item clinical assessment tool used to evaluate the severity of neurologic deficits in patients with acute stroke. The total NIHSS score ranges from 0 to 42, where: 0 = no stroke symptoms Higher scores indicate greater stroke severity and worse neurological outcomes The scale includes assessments of level of consciousness, gaze, visual fields, motor strength, limb ataxia, sensory function, language, and neglect.

Time frame
7 days
2

Functional status at discharge (modified Rankin Scale)

The patient's functional outcome will be assessed at discharge using the modified Rankin Scale (mRS), which ranges from 0 (no symptoms) to 6 (death). The distribution of mRS scores will be analyzed in relation to transcranial Doppler findings, including mean flow velocity, pulsatility index, and flow pattern, to determine their prognostic significance.

Time frame
At hospital discharge (within 14 days of admission)

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Jose Ivan Rodriguez de Molina Serrano

Lead sponsor

Clinica Mexico

Sponsor institution

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